Intracranial CNS DisorderAWFNCT03751085
A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain
A study testing AW frame in people with Intracranial CNS Disorder, run by Ministry of Health, Malaysia at 3 sites in Malaysia.
Trial summary
This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial CNS Disorder
- What is being tested?
- AW frame
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesMalaysia
- Study dates
- 18 Jul 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >17 years old
- Radiological diagnosis of intracranial space occupying lesion of any etiology
Who cannot join
- Patient involved in other study trial
- Any serious medical condition that according to the investigator could interfere with the conduct of the study
- Unwillingness or inability to comply with study requirements
Trial locations and contacts
3 sites in 1 country.
Malaysia3 sites, 3 recruiting
- Recruiting
Department of Neurosurgery, Sarawak General Hospital
Kuching, Sarawak, 93586
Bik Liang Lau, MD, +60128822977, laubikliang@gmail.com
Albert Sii Hieng Wong, FRACS, +60128899863, wonghm96@yahoo.com
- Not yet recruiting
Hospital Miri
Miri, Sarawak, 98000
Bik Liang Lau, MD, +60128822977, laubikliang@gmail.com
Albert Sii Hieng Wong, FRACS, +60128899863, wonghm96@yahoo.com
- Not yet recruiting
Department of Neurosurgery, Hospital Sibu
Sibu, Sarawak, 96000
Bik Liang Lau, MD, +60128822977, laubikliang@gmail.com
Albert Sii Hieng Wong, FRACS, +60128899863, wonghm96@yahoo.com
About this study
This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery.
Read the detailed description
AW frame is a stereotactic biopsy frame created by Dr. Albert Sii Hieng Wong. A phantom study had completed by Dr. Bik Liang Lau and Dr. Albert Sii Hieng Wong in year 2017 with good accuracy. The phantom study result is going to be submitted for publication by early 2019.
With the good accuracy of AW frame in the phantom study, the frame has been approved by the Medical Research \& ethic committee (MREC) for human use in a research setting.
In the study, patient with intracranial lesion which required biopsy, whom fulfilled the criteria will be recruited. All these patient will underwent standard biopsy procedure either under local or general anaesthesia with AW frame mounted.
A localisation CT scanning will be perform with localiser fixed onto the head frame. Target of the intracranial lesion is selected. The coordinates of the localizing points and the selected target inserted into the AW stereo-calculator to generate the AW frame setting up measurements.
Burr hole will be performed and biopsy taken by using Nashold® biopsy needle. An immediate post-biopsy CT imaging will be performed to confirm the site of the biopsy. Patient will be monitored in the neurosurgery ward for any complications.
Histopathologic analysis of the biopsies will be done using usual procedure.
- Conditions
- Intracranial CNS Disorder
- Being tested
- AW frame
- Keywords
- AW frame, biopsy, stereotactic, accuracy, safety
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AW frameDevice
AW stereotactic frame for intracranial lesion biopsy
| Study group | Role | What they receive |
|---|---|---|
| AW frame | Experimental | AW frame biopsy Receives: Device: AW frame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
The diagnostic yield is defined as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the biopsy.
Measured: For each patient 2 week after the biopsy
Number of participants presenting with post-biopsy complications
The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the biopsy, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological evidence.
Measured: an average of 2 week
Secondary outcomes (2)
Time
the preparation, operation and total operating room time
Measured: From the time of the participant is transferred to the OR until the time of the participant transfer out of it, assessed on the day of operation.
Length of hospital stay
The preoperative, postoperative and total length of hospital stay
Measured: an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start18 Jul 2018
- Primary completion17 Jul 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial CNS DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lau Bik Liang, Ministry of Health, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751085
- Sponsor's protocol ID
- NMRR-17-3247-36799
- Acronym
- AWF
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain
- ClinicalTrials.gov ID
- NCT03751085
- Acronym / sponsor ID
- AWF / NMRR-17-3247-36799
- Conditions
- Intracranial CNS Disorder
- Keywords
- AW frame, biopsy, stereotactic, accuracy, safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 17 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery.
Detailed description
AW frame is a stereotactic biopsy frame created by Dr. Albert Sii Hieng Wong. A phantom study had completed by Dr. Bik Liang Lau and Dr. Albert Sii Hieng Wong in year 2017 with good accuracy. The phantom study result is going to be submitted for publication by early 2019.
With the good accuracy of AW frame in the phantom study, the frame has been approved by the Medical Research \& ethic committee (MREC) for human use in a research setting.
In the study, patient with intracranial lesion which required biopsy, whom fulfilled the criteria will be recruited. All these patient will underwent standard biopsy procedure either under local or general anaesthesia with AW frame mounted.
A localisation CT scanning will be perform with localiser fixed onto the head frame. Target of the intracranial lesion is selected. The coordinates of the localizing points and the selected target inserted into the AW stereo-calculator to generate the AW frame setting up measurements.
Burr hole will be performed and biopsy taken by using Nashold® biopsy needle. An immediate post-biopsy CT imaging will be performed to confirm the site of the biopsy. Patient will be monitored in the neurosurgery ward for any complications.
Histopathologic analysis of the biopsies will be done using usual procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AW frame | Experimental | Device: AW frameAW frame biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >17 years old
- Radiological diagnosis of intracranial space occupying lesion of any etiology
Key exclusion criteria (3 listed)
- Patient involved in other study trial
- Any serious medical condition that according to the investigator could interfere with the conduct of the study
- Unwillingness or inability to comply with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AW frameAW stereotactic frame for intracranial lesion biopsy | Device | AW frame |
Primary outcome
Diagnostic yield
Time frame: For each patient 2 week after the biopsy
The diagnostic yield is defined as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the biopsy.
Number of participants presenting with post-biopsy complications
Time frame: an average of 2 week
The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the biopsy, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological evidence.
2 secondary outcomes
Time
Time frame: From the time of the participant is transferred to the OR until the time of the participant transfer out of it, assessed on the day of operation.
Length of hospital stay
Time frame: an average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AW frame in people with Intracranial CNS Disorder, run by Ministry of Health, Malaysia at 3 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bik Liang Lau, MD (+60128822977, laubikliang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: For each patient 2 week after the biopsy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.